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Clinical Trials List

Protocol NumberC6461020

NCT Number(ClinicalTrials.gov Identfier)NCT07227298

Active

2026-02-23 - 2030-03-31

Phase I

Not yet recruiting6

AN INTERVENTIONAL OPEN-LABEL PHASE 1B/2 STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS, AND PRELIMINARY EFFICACY OF PF-08634404 IN COMBINATION WITH DIFFERENT ANTICANCER AGENTS IN PARTICIPANTS WITH ADVANCED SOLID TUMORS

Sponsor
Trial scale

Multi-Regional Multi-Center
Update

2026/09/10

Investigators and Locations

Principal Investigator Yung-Hung Luo Division of Thoracic Medicine

Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 蘇健 Division of Thoracic Medicine

MacKay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Jen-Yu Hung Division of Thoracic Medicine

Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator CHIN-CHOU WANG Division of General Internal Medicine

Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Chia-Chi Lin Division of Hematology & Oncology

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Chien-Chung Lin

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Condition/Disease

Advanced/Metastatic Non-Small Cell Lung Cancer

Objectives

旨在評估 PF-08634404 併用不同 ADCs (包括 sigvotatug vedotin 和 PF-08046054) 是否可以在第一線情境下改善無可作用基因組改變 (actionable genomic alterations, AGA) 之鱗狀和非鱗狀 LA/M NSCLC 參與者的臨床結果

Test Drug

輸注液
注射用凍晶粉末
注射用凍晶粉末

Active Ingredient

PF-08634404
PF-08046047 (Sigvotatug Vedotin)
PF-08046054 (SGNPDL1V)

Dosage Form

27C
048
048

Dosage

200 mg/ 10mL/ Vial
30 mg/ Vial
40 mg/ Vial

Endpoints

Phase 1b
• AE 依類型、頻率、嚴重程度 (按 NCI CTCAE 第 5.0 版分級)、時間點、嚴重性和試驗介入治療的關係描述特性。
• DLT。
Phase 2
• 試驗主持人依 RECIST v1.1 確認的 ORR
• AE 依類型、頻率、嚴重程度 (按 NCI CTCAE 第 5.0 版分級)、時間點、嚴重性和試驗介入治療的關係描述特性。

Inclution Criteria

Inclusion Criteria:

Pathologically confirmed locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) squamous or non-squamous NSCLC and are not a candidate for complete surgical resection and curative concurrent/sequential chemoradiotherapy
PD-L1 status available
Part B only: PD-L1 ≥ TPS 1%
Measurable disease based on RECIST v1.1 per investigator.
Eastern Cooperative Oncology Group performance status of 0 or 1.
Adequate organ function

Exclusion Criteria

Exclusion Criteria:

Participants with known AGAs including EGFR, ALK and ROS1, NTRK, BRAF, and MET
History of another malignancy within 3 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy
Known active CNS lesions, including brainstem, meningeal, or spinal cord metastases or compression
Leptomeningeal disease
Active autoimmune diseases requiring systemic treatment within the past 2 years
Previous systemic anti-tumor therapy for locally advanced, unresectable, or metastatic NSCLC
Previous treatment with immunotherapy (exception is (neo)adjuvant anti-PD-(L)1), ADCs containing MMAE payload, systemic anti-angiogenic therapy, or prior radiotherapy to the lung within 6 months of first dose of study intervention

The Estimated Number of Participants

Taiwan

24 participants
Global

162 participants